Promoting Mental and Cognitive Health in Old Age Through Scalable Evidence-based Interventions (PROMISE)

PROMISE: Promoting Mental and Cognitive Health in Old Age Through Scalable Evidence-Based Interventions - Study Protocol for a Randomized Controlled Trial

Mental and cognitive health are key determinants of healthy and successful aging. These two domains are closely intertwined: while chronic stress can impair cognitive functioning, cognitive decline may in turn heighten stress and reduce overall well-being in older adults. This project aims to evaluate the effectiveness and scalability of a multidomain intervention to support mental and cognitive health in older adults. A single-blind, randomized, controlled 2×2 factorial trial will be conducted with a large sample of community-dwelling adults aged 65 years and older in the German- and French-speaking regions of Switzerland. Participants will be randomly assigned to one of four intervention arms: (1) WHO Self-Help Plus stress management training (SH+), (2) multidomain cognitive training focused on lifestyle and behavior change (COG), (3) a combined SH+ and COG intervention (SH+/COG), or (4) an active control group (CG) involving podcast listening and discussion. All interventions will include in-person group sessions, while the SH+, COG, and SH+/COG arms additionally offer a digital platform for self-guided home training. Primary outcomes (mental and cognitive health), secondary outcomes and moderators (cognitive functioning, stigma, self-efficacy, self-concept, loneliness, digital literacy, cognitive reserve, sociodemographic variables) will be assessed at baseline, post-intervention (10 weeks), and at 2- and 6-month follow-ups through a self-administered ambulatory assessment.

Study Overview

• Status: Not yet recruiting
• Conditions: Cognition; Ageing; Well-Being, Psychological
• Intervention / Treatment: Behavioral: Stress management training; Behavioral: Multidomain cognitive training; Behavioral: Social activities

• Study Type: Interventional
• Enrollment (Estimated): 1000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Matthias Kliegel, Professor; Phone Number: +41 22 379 9176; Email: matthias.kliegel@unige.ch

Study Locations

• Switzerland
  • Geneva, Switzerland, 1227
    • Center for the Interdisciplinary Study of Gerontology and Vulnerabilities
    • Contact: Matthias Kliegel, Professor; Phone Number: +41 22 379 9176; Email: matthias.kliegel@unige.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Aged 65 years or older.
• Ability to speak and read the official language of their place of residence (French or German).
• Ability to use and access a digital device for a digital training platform provided for the training.

Exclusion Criteria:

• Aged below 65.
• Inability to use and lack of access to a digital device required for using the digital training platform.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stress management training Self-Help+ (SH+)	Behavioral: Stress management training; The stress management training is the WHO SH+ (Self-Help Plus) program, a low-intensity, group-based intervention developed by the World Health Organization to improve stress management and psychological flexibility. It combines pre-recorded audio sessions with an illustrated self-help guide and is based on Acceptance and Commitment Therapy (ACT). The program is delivered over five sessions and supported by a digital platform for at-home practice.
Experimental: Multodomain cognitive training (COG)	Behavioral: Multidomain cognitive training; The multidomain cognitive training is a low-intensity, group-based intervention aimed at sustainably improving a healthy lifestyle, which in turn supports brain health and cognitive functioning. It combines pre-recorded audio sessions with an illustrated self-help guide and provides knowledge about aging and how to enhance three key lifestyle factors-social engagement, physical activity, and cognitive stimulation. The training uses metacognitive strategies and monitoring tools to help participants sustainably integrate these behaviors into their daily lives. The program is delivered over five sessions and supported by a digital platform for at-home practice.
Experimental: SH+ and COG combined	Behavioral: Stress management training; The stress management training is the WHO SH+ (Self-Help Plus) program, a low-intensity, group-based intervention developed by the World Health Organization to improve stress management and psychological flexibility. It combines pre-recorded audio sessions with an illustrated self-help guide and is based on Acceptance and Commitment Therapy (ACT). The program is delivered over five sessions and supported by a digital platform for at-home practice.; Behavioral: Multidomain cognitive training; The multidomain cognitive training is a low-intensity, group-based intervention aimed at sustainably improving a healthy lifestyle, which in turn supports brain health and cognitive functioning. It combines pre-recorded audio sessions with an illustrated self-help guide and provides knowledge about aging and how to enhance three key lifestyle factors-social engagement, physical activity, and cognitive stimulation. The training uses metacognitive strategies and monitoring tools to help participants sustainably integrate these behaviors into their daily lives. The program is delivered over five sessions and supported by a digital platform for at-home practice.
Active Comparator: Podcast discussions	Behavioral: Social activities; The social activity intervention consists of a podcast discussion group in which participants listen to short podcasts on aging-related topics during each group session. Topics include driving (Session 1), intergenerational relationships (Session 2), technology (Session 3), the transition to retirement (Session 4), and travel (Session 5). These themes are deliberately chosen to be neutral and are not directly related to the techniques or content used to enhance well-being or cognitive functioning in the SH+ or COG interventions. The program is delivered over five sessions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health related quality of life	Measurement tool: EuroQol Five-Dimensional Five-Level Scale (EQ-5D-5L; Herdman et al., 2011); Unit of measure: EQ-5D-5L index score (country-specific value set; range: -0.661 to 1.000 for Germany). Higher values on the EQ-5D index indicate better health status.	Assessed before the intervention begins (pretest), after it concludes (10 weeks, posttest), and at two follow-ups: one at 2 months and another at 6 months post-intervention.
Well-being	Measurement tool: Capability Index for Older People, Scale (ICECAP-O; Gustafsson & Horder, 2022; Coast et al., 2008); Unit of measure: The ICECAP-O assesses five core dimensions of well-being relevant to older adults (attachment, security, role, enjoyment, control). ICECAP-O scores on the five core dimensions range from 1 to 4, with 1 being the lowest and 4 being the highest. These raw scores are then converted to tariff scores, ranging from 0 (representing absence of capability) to 1 (representing full capability).	Assessed before the intervention begins (pretest), after it concludes (10 weeks, posttest), and at two follow-ups: one at 2 months and another at 6 months post-intervention.
Psychological distress	Measurement tool: Kessler Psychological Distress Scale (K6; Kessler et al., 2002); Unit of measure: K6 total score ranges from 0 to 24, with higher values indicating greater psychological distress.	Assessed before the intervention begins (pretest), after it concludes (10 weeks, posttest), and at two follow-ups: one at 2 months and another at 6 months post-intervention.
Depression	Measurement tool: Geriatric Depression Scale - Short Form, Scale (GDS-SF; Sheikh & Yesavage, 1986); Unit of measure: GDS-SF total score ranges from 0 to 15, with higher scores indicating higher levels of depression.	Assessed before the intervention begins (pretest), after it concludes (10 weeks, posttest), and at two follow-ups: one at 2 months and another at 6 months post-intervention.
Anxiety	Measurement tool: Geriatric Anxiety Inventory - Short Form, Scale (GAI-SF; Byrne & Pachana, 2010); Unit of measure: The GAI-SF total score ranges between 0 to 5, with higher scores representing higher anxiety levels.	Assessed before the intervention begins (pretest), after it concludes (10 weeks, posttest), and at two follow-ups: one at 2 months and another at 6 months post-intervention.
Cognitive health	Measurement tool: Brain Care Score, Scale (self-designed scale based on Singh et al., 2023; Livingston et al., 2020; Ngandu et al., 2015); The Brain Care Score assesses six key dimensions known to be related to brain health: exercise, cognitive stimulation, social engagement, stress, sleep, and nutrition. Scores on the six dimensions range from 1 to 5. The total score ranges from 6 to 30, with higher scores indicating a lifestyle more supportive of brain health.	Assessed before the intervention begins (pretest), after it concludes (10 weeks, posttest), and at two follow-ups: one at 2 months and another at 6 months post-intervention.
Health related quality of life	Measurement tool: EuroQol Five-Dimensional Five-Level Scale (EQ-5D-5L; Herdman et al., 2011); Unit of measure: EQ-5D-5L index score (country-specific value set; range: -0.661 to 1.000 for Germany) and Visual Analog Scale (VAS; range: 0-100). Higher values on the EQ-5D index indicate better health status, and higher values on the VAS also indicate better perceived health.	Assessed before the intervention begins (pretest), after it concludes (10 weeks, posttest), and at two follow-ups: one at 2 months and another at 6 months post-intervention.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived health	Measurement tool: EuroQol Five-Dimensional Five-Level Scale (EQ-5D-5L; Herdman et al., 2011); Unit of measure: Visual Analog Scale (VAS; range: 0-100). Higher values on the VAS indicate better perceived health.	Assessed before the intervention begins (pretest), after it concludes (10 weeks, posttest), and at two follow-ups: one at 2 months and another at 6 months post-intervention.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall cognitive functioning	Measurement tool: Cognitive Telephone Screening Instrument, Scale (COGTEL, online version: E-COGTEL; Kliegel et al., 2007); Unit of measure: The total COGTEL score is derived from the sum of the weighted scores of each of the six subtests. A high score indicates better global cognitive functioning.	Assessed before the intervention begins (pretest), after it concludes (10 weeks, posttest), and at two follow-ups: one at 2 months and another at 6 months post-intervention.
Abstract reasoning and fluid intelligence	Measurement tool: Raven Advanced Progressive Matrices - Short Form, Scale (APM; Arthur & Day, 1994; Raven et al., 1985); Unit of measure: The APM total score ranges from 0 to 12 points, with higher scores indicating a higher general cognitive ability.	Assessed before the intervention begins (pretest), after it concludes (10 weeks, posttest), and at two follow-ups: one at 2 months and another at 6 months post-intervention.
Subjective cognitive complaints	Measurement tool: Subjective Cognitive Complaints Questionnaire (self-designed; Geerlings et al., 1999; Jessen, 2010; EIlis et al., 2014); Unit of measure: This instrument consists of five yes/no items that assess both perceived memory decline and related concerns.	Assessed before the intervention begins (pretest), after it concludes (10 weeks, posttest), and at two follow-ups: one at 2 months and another at 6 months post-intervention.
Perceived age discrimination	Measurement tool: Perceived Experiences of Age Discrimination Scale (PAD; De Paula Couto et al., 2023); Unit of measure: The PAD total score ranges from 0 to 4, with higher scores indicating a greater frequency or intensity of perceived age discrimination.	Assessed before the intervention begins (pretest), after it concludes (10 weeks, posttest), and at two follow-ups: one at 2 months and another at 6 months post-intervention.
Age-related stereotype threat	Measurement tool: Age-related Stereotype Threat Scale (not yet published version); Unit of measure: Higher total scores indicate greater age-related stereotype threat.	Assessed before the intervention begins (pretest), after it concludes (10 weeks, posttest), and at two follow-ups: one at 2 months and another at 6 months post-intervention.
Self-efficacy	Measurement tool: Generalized Self-Efficacy Scale (GSE; Jerusalem & Schwarzer, 1992); Unit of measure: The total GSE score ranges from 10 to 40, with higher values indicating a stronger generalized sense of self-efficacy.	Assessed before the intervention begins (pretest), after it concludes (10 weeks, posttest), and at two follow-ups: one at 2 months and another at 6 months post-intervention.
Self-concept	Measurement tool: Subjective Aging Perception Scale (SAPS; De Gracia et al., 1999); Unit of measure: The SAPS assesses four dimensions of individuals' perceptions and attitudes toward their own aging process (perceived self-care, perceived social resources, cognitive self-competence, perceived time structure). Scores on the four dimensions vary between 3 and 20, with higher scores indicating more positive perceptions of aging.	Assessed before the intervention begins (pretest), after it concludes (10 weeks, posttest), and at two follow-ups: one at 2 months and another at 6 months post-intervention.
Social support	Measurement tool: Lubben Social Network Scale - 6 items (LSNS-6; Lubben et al., 2006); Unit of measure: The total LSNS-6 score ranges from 0 to 30. Higher scores indicate a larger, more active social network and stronger social connections.	Assessed before the intervention begins (pretest), after it concludes (10 weeks, posttest), and at two follow-ups: one at 2 months and another at 6 months post-intervention.
Loneliness	Measurement tool: De Jong Gierveld 6-item Loneliness Scale (DJGLS-6; De Jong Gierveld & Van Tilburg, 2006); Unit of measure: The DJGLS-6 total score ranges from 1 to 5, with higher scores indicating greater loneliness.	Assessed before the intervention begins (pretest), after it concludes (10 weeks, posttest), and at two follow-ups: one at 2 months and another at 6 months post-intervention.
Digital literacy	Measurement tool: Senior Technology Acceptance Model - Short Form, Scale (Short STAM; Chen & Lou, 2020); Unit of measure: The Short STAM total score ranges from 14 to 140, with higher scores indicating greater technology acceptance.	Assessed before the intervention begins (pretest).
Cognitive reserve	Measurement tool: Cognitive Reserve Index questionnaire, Scale (CRIq; Nucci et al., 2012); Unit of measure: The total CRIq score is standardized: the average is 100, with a standard deviation of 15. Higher values indicate greater cognitive reserve.	Assessed before the intervention begins (pretest).
Subjective social status	Measurement tool: MacArthur Scale of Subjective Social Status, Scale (MacArthur SSS Scale; Adler et al., 2000); Unit of measure: The MacArthur SSS score ranges from 1 to 100, with higher values indicating a higher perceived social status.	Assessed before the intervention begins (pretest).
Cost of services	Measurement tool: Client Service Receipt Inventory (CSRI; Chisholm et al., 2000); Unit of measure: Different questions gather information on health and social care service use, informal care, employment and income, living situation and housing, as well as medication and treatment adherence. This information will be used to estimate total costs per participant over the past two months.	Assessed before the intervention begins (pretest), after it concludes (10 weeks, posttest), and at two follow-ups: one at 2 months and another at 6 months post-intervention.
Session attendance	Measurement tool: Facilitator Attendance Logs; Unit of measure: Number of attended sessions: ranges from 0 to 10, with higher numbers indicating greater session attendance.	Between pretest and posttest (10 weeks).
Usage of digital platform	Measurement tool: Digital platform usage data; Unit of measure: The platform gathers information on different usage markers such as number of logins, number of completed training sessions, total time spent on the platform, and number of days with at least one activity. Higher values indicate greater engagement with the digital intervention.	From pretest until follow-up 2 (8 months).

Collaborators and Investigators

• Sponsor: University of Geneva, Switzerland

Publications and helpful links

Helpful Links

• Project website
• Information for participants

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: June 13, 2025
• First Submitted That Met QC Criteria: July 15, 2025
• First Posted (Estimated): July 18, 2025

Study Record Updates

• Last Update Posted (Estimated): July 18, 2025
• Last Update Submitted That Met QC Criteria: July 15, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: cognitive function; mental health; well-being; cognitive training; cognitive health; healthy aging; Acceptance and commitment therapy; stress-management training; lifrstyle intervention
• Other Study ID Numbers: 101080323

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No